Did a patent or generic-entry record change?

Which records should a team watch?

For a U.S. marketed drug, start with the FDA Orange Book data files for listed patents and exclusivity and the FDA Paragraph IV certification list for published challenge information. Relevant patent office and approval records can add context. The useful watch is specific to the drug’s products, applications, and the records actually available; see the source map.

• A new or changed listed patent or exclusivity date
• A Paragraph IV certification against a product or strength
• A later FDA approval or other public generic-entry milestone

What did the Zepbound example reveal?

In the dated What changed sample, the FDA Paragraph IV list showed August 24 and 26, 2026 certifications against Zepbound’s 20, 30, 40, and 50 mg KwikPen strengths, following June certifications against the 10 and 60 mg strengths. The before-and-after finding is specific: challenges went from two of six strengths to all six. The sample identifies the FDA list as of September 28, 2026 and links to the original FDA page.

This is brand-level evidence about the listed Zepbound products. It should not be assigned to every tirzepatide brand as the same brand-specific challenge.

What does a Paragraph IV certification mean?

It records a generic applicant’s position that a listed patent is invalid, unenforceable, or will not be infringed by its product. It is a competitive signal, not an FDA conclusion on the patent, approval of the generic, or proof of when a generic will launch. Patent and exclusivity dates are also different protections; a single listed expiry does not determine an entry date. FDA explains the distinction.

How does this appear in a watch?

A What changed report ties the new public record to the watched product, shows the prior and current position when the data supports it, and cites the source and check date. The free coverage check identifies the relevant products and records first. Publication schedules vary, so the report does not imply a source changed on a day it was merely checked.

Read how Watchtower checks and attributes findings →